MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SURESIGNS VM 6 PATIENT MONITOR

Model Number	863064
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an alarm did not work after the booting up of the suresigns vm6 patient monitor.The device was not in use monitoring a patient at the time of the reported issue.No adverse event was reported.
Additional Manufacturer Narrative
Reporting institution phone number: (b)(6) reporter phone number: (b)(6) philips has received a complaint on the suresigns vm6 patient monitor indicating "an alarm did not work after the booting up of the patient monitor.¿ the device was not in clinical use during the event and no potential or actual harm was reported or occurred.The customer reached out to philips via a national medical products administration report (nmpa#(b)(4)) requesting an investigation of the issue.A philips remote service engineer reached out to the customer to confirm the issue.It is not known if any functional tests were done on the device.It was asked but unknown which parameter alarm was affected or what type of alarm was the customer expecting.However, there was a problem with a dead battery involved in the alarm issue.It is not known if the faulty battery was a philips product or a third party device.The hospital equipment department replaced the battery and the equipment returned to normal use.Based on the information available and the testing conducted, the cause of the reported problem was a dead battery.The customer replaced the battery to resolve the issue.It has been concluded that no further action is required at this time.The device remains at the customer site.

• Brand Name: SURESIGNS VM 6 PATIENT MONITOR
• Common Device Name: SURESIGNS VM 6 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18168998
• Report Number: 1218950-2023-00867
• Device Sequence Number: 20762522
• Product Code: MHX
• UDI-Device Identifier: 00884838000049
• UDI-Public: 00884838000049
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 863064
• Device Catalogue Number: 863064
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown